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Ascend Laboratories, LLC

Ascend Laboratories, LLC Recalls

All product recalls associated with Ascend Laboratories, LLC.

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 321–340 of 7756 recalls

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

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FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Bontrager 7ROD (Bontrager Outdoors) – Carbon Monoxide Detection (2025)

Bontrager Outdoors (Bontrager) is recalling certain 2025 Skinny Guy Campers Armor 7LT and Bontrager Outdoors 7ROD trailers. The carbon monoxide detectors may not have been installed.

NHTSAJul 8, 2025Nationwide• BONTRAGER OUTDOORS

Carotid WALLSTENT (Boston Scientific) – Insertion Resistance (2025)

Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.

FDAJul 7, 2025Nationwide• Boston Scientific Corporation

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

FDAJun 30, 2025Nationwide• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

Laser Light Show Projectors (Beyond Laser) – Remote Interlock Issue (2025)

The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.

FDAJun 30, 2025Nationwide• Beyond Laser Systems, LLC

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAJun 30, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

Device does not comply with the labeling requirements of international standard IEC 60601-1.

FDAJun 27, 2025Nationwide• Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany

Injection Needle (Spiggle & Theis) – Cytotoxicity Risk (2025)

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

FDAJun 27, 2025Nationwide• Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany

UIBC Assay (Beckman Coulter) – Hemoglobin Interference (2025)

Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.

FDAJun 26, 2025AL, AK, AR +8 more• Beckman Coulter Inc.

LiPRO Battery Packs (DR Power) – fire hazard (2025)

Fire/Burn Risk

This recall involves 62-volt 5.0 Ah LiPRO rechargeable lithium-ion battery packs for use with DR Power brand battery-powered products, such as lawnmowers, trimmers and snow throwers. The products include stand-alone battery packs with model number 414240, and removeable battery packs included with DR Power outdoor yard equipment items with model numbers 524340, SB11022XEN, T4X3026XEN, T4X3062XENR, CE75021XEN0 and CE77021XEN0. Information containing the model number for the battery pack ("41424") is located on the battery pack's label. The LiPRO and DR Power logo are on the front and side panels of the battery pack. Note: Do not throw this recalled lithium-ion battery or device in the trash, the general recycling stream (e.g., street-level or curbside recycling bins), or used battery recycling boxes found at various retail and home improvement stores. Recalled lithium-ion batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center may accept this recalled lithium-ion battery or device for disposal. Before taking your battery or device to a HHW collection center, contact that office ahead of time and ask whether it accepts recalled lithium-ion batteries. If it does not, contact your municipality for further guidance.

CPSCJun 26, 2025Nationwide• Ningbo New Team Import & Export Co. Ltd. ("Lera"), of China

FARAWAVE Ablation Catheter (Boston Scientific) – Electrode Band Crack (2025)

The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

FDAJun 25, 2025Nationwide• Boston Scientific Corporation

DxI 800 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

FDAJun 25, 2025Nationwide• Beckman Coulter, Inc.

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Downstream recall of a dietary supplement ingredient that was manufactured out of specification.

Class IIILow

FDAJun 24, 2025CA, IN, OK• GMP Laboratories of America Inc

Stay Informed

Ascend Laboratories, LLC Recalls

Recall Summary

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Bontrager 7ROD (Bontrager Outdoors) – Carbon Monoxide Detection (2025)

Carotid WALLSTENT (Boston Scientific) – Insertion Resistance (2025)

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)

Laser Light Show Projectors (Beyond Laser) – Remote Interlock Issue (2025)

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

Injection Needle (Spiggle & Theis) – Cytotoxicity Risk (2025)

UIBC Assay (Beckman Coulter) – Hemoglobin Interference (2025)

LiPRO Battery Packs (DR Power) – fire hazard (2025)

FARAWAVE Ablation Catheter (Boston Scientific) – Electrode Band Crack (2025)

DxI 800 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

UniCel DxI 800 Analyzer (Beckman Coulter) – Software Issue (2025)

DxI 600 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

UniCel DxI 600 Analyzer (Beckman Coulter) – Software Issue (2025)

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)